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Katie Fillinger of NSF International’s Health Sciences Certification program explains some possible cGMP certification pathways.
With consumers demanding greater transparency and retailers facing legal exposure and regulatory warnings, many major retailers and online platforms are now requiring dietary supplement brands to provide proof of compliance with current Good Manufacturing Practices (cGMP). Amazon updated its dietary supplement seller requirements in April 2021 and no doubt continues to review those requirements. CVS Health launched its Tested to be Trusted program in 2019. Both programs require brands and manufacturers to provide independent, third-party certification of GMP compliance as well as other quality and testing requirements. Already, we are seeing other retailers follow suit.
For dietary supplement manufacturers, compliance with cGMPs should be nothing new. All dietary supplement manufacturing facilities have been required to comply with 21 CFR 111 for years—but independent certification of compliance is new territory for many brands. Fortunately, there are several ways to document a manufacturing facility’s cGMP compliance. I’m writing this article to help you choose the cGMP certification path—and level of transparency—that will work best for your business.
Three paths to GMP certification are:
Let’s take a closer look at each of these options.
Major retailers and manufacturers have joined together as the Global Retailer and Manufacturer Alliance (GRMA) to create and manage harmonized quality requirements in several non-food related industries, including dietary supplements.The GRMA is a member-based organization with broad industry support from key global retailers within the grocery, drug, mass merchandiser, and club store channels. Members include retailers, manufacturers, trade associations, certification bodies, and other stakeholders.
When you join the GRMA, you agree to meet the requirements of the GRMA’s GMP audit program, which is based on a consensus standard known as NSF/ANSI 455-2 – Good Manufacturing Practices for Dietary Supplements. As a GRMA member, you can benefit from the ability to share the results of your GMP audits with other members of the group, which includes a growing list of retailers. This level of transparency is designed to help participating retailers find brands and manufacturing facilities that meet the GRMA requirements. Audits are performed by your choice of three approved certification bodies: NSF International, UL, or Perry Johnson Registrars. Upon completion of the audit, your audit reports are published on the GRMA web portal and can be visible to other GRMA members. If you pass the audit, you’ll receive GRMA certification and NSF/ANSI 455-2 certification from the certifier. You’ll also have permission to use the GRMA logo on your website.
NSF/ANSI 455-2 GMP Certification
Another option is independent certification of GMPs. Several years ago, NSF International’s standards development organization convened a balanced committee of supplement industry representatives, public health officials, regulators, and consumer interest groups to develop NSF/ANSI 455-2, a consensus American National Standard for dietary supplement GMPs. The GRMA participated in the development of the standard and, as mentioned previously, now uses NSF/ANSI 455-2 as the foundation of its own auditing scheme. But you don’t need to be a GRMA member to use the GMP standard. Since NSF/ANSI standards are publicly available, any retailer or manufacturer can use NSF/ANSI 455-2 as a guidance document. Or, you can engage NSF to audit and certify your facility to the NSF/ANSI 455-2 GMP standard. Certified facilities are publicly listed on NSF’s website and are provided with a certificate and audit report, along with permission to use the NSF certification mark on your website and marketing materials.
Independent Product Certification
A third option is independent certification of your products. Both the GRMA and NSF/ANSI 455-2 audits are focused on GMPs at manufacturing facilities. In those cases, it’s the facility that gets certified, not a specific product. But if you want to go beyond GMP compliance, you can work with an accredited certification body to have your individual products certified. For example, product certification to NSF/ANSI 173: the American National Standard for Dietary Supplements starts with the foundation of facility certification to the NSF/ANSI 455-2 standard. From there, product formulation and label claims are reviewed to determine compliance with the standard, and laboratory tests are performed to identify contaminants like heavy metals, pesticides, and microbiological contamination. Beyond meeting the most stringent retailer requirements, independent certification of individual products can be a powerful marketing tool.
What’s Right for You?
With three options to choose from, how do you know which GMP assurance path is right for you? A lot depends on your sales and distribution model. If retail is an important part of your business model, then membership in the GRMA probably makes the most sense. Membership is affordable and gives you access to many leading retailers. Your membership helps demonstrate your commitment to good manufacturing practices and may even open doors to new relationships with top retailers. However, you’ll need to keep in mind that you are committing to true transparency when you join.
If retail is not a big part of your business model—let’s say you sell direct to consumers via your own website—then joining the GRMA might not make sense for you. In this case, you might want to have your manufacturing facility audited and certified to the NSF/ANSI 455-2 GMP standard. Consumers are becoming increasingly savvy about product quality, and proof of GMP compliance can be an important marketing differentiator for your brand. If retail is important to you but you aren’t quite ready for the transparency of GRMA membership, you might start out with an independent audit and certification to the NSF/ANSI 455-2 GMP standard and then join the GRMA when it makes sense for you and your business.
Product certification might be right for you if you want to demonstrate the highest level of quality and safety assurance. For manufacturers of supplements in the high-risk categories—pre-workout, muscle building, weight loss, and sexual enhancement—product certification can be an essential part of your marketing strategy as consumers are becoming increasingly concerned about the quality and safety of these products.
Whichever path you choose, it’s time to get underway and start your GMP certification journey. We envision a future when most major retailers will require brands to show proof of product quality in some form or another, whether through independent assurance of GMP compliance, independent laboratory testing of products, or both. Proof of GMP compliance might soon be a prerequisite for retail sales.
Katherine Fillinger is the certification program manager for NSF International’s (Ann Arbor, MI) Health Sciences Certification program. She has served at NSF International for 13 years, including 10 years in the dietary supplement certification program. She holds a master’s degree in management, strategy, and leadership from Michigan State University and a bachelor’s degree in business administration from Eastern Michigan University.